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neuroinv

09/15/09 2:57 PM

#28618 RE: gfp927z #28617

It's not the absolute number of patients, it's the (apparent) clarity of the trend. If they have (to make up numbers) eight patients who show a 60% decrease in apnea frequency, whereas the two placebo patients show no change (there is some question as to whether there is a placebo effect in apnea trials)--that's going to be sufficient. But if there is a fair amount of variability amongst the patients, then it becomes ambiguous, and quickly.

I had an interesting conversation a couple weeks ago with a BP for whom I am providing some licensing consultation (unfortunately, there is virtually no overlap between their interests and Cortex's available assets) about what constitutes POC--proof of concept. The fact is that no Phase IIa study really 'proves' a concept, it may take PhIIb or even PhIII to really 'prove' it (the latter, in the case of the FDA). So I suggested the term HOC--'Hint of Concept.' You don't need p=.05 for HOC.

Deals are being made where the initial upfront is not as large as it would be with a more robust PhII dataset, but if a larger PhII trial confirms HOC/POC. a second milestone is paid which makes the small company 'whole.' That could be another avenue for a SA deal.

NeuroInvestment
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jerrydylan

09/15/09 3:01 PM

#28620 RE: gfp927z #28617

I have always said to them they need a real partner who is determined to commercialize and succeed together. I used the comparison to Roche and Genentech ( who was really more or less broke in 1992-1993 period) Roche knew they had great ideas and technology, they really needed enough money and cut themselves a hellaciously good deal but it kept DNA alive and .....you know the rest. Well, I am not comparing us to DNA but it's not a bad analogy, on a small scale. They want this kind of deal because we have discussed it, ( on a much smaller scale) the problem is now the low stock price. I think they have interest, which we heard Varney confirm but to a pinhead from BP whose job is not a guarantee anymore who sees a $13 million cap, how or why would you take a $30 million upfront to a higher up as something that you want to do, think should be done when budgets are shrinking? Even lower amount? It is a problem and my own personal opinion is the currency was left to the market without the understanding of how important it was to their survival-to attempt to defend it by soliciting interest, no names mentioned. They shrugged their shoulders...here we are. They know that clinical trials success is the eventual savior, having money comes from somewhere to .....or you need a partner.